Aseptic CAR-T Manufacturing Lead Operator

Legend Biotech, Inc.; Raritan (NJ); On-site; USD 83,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Eight weeks paid parental leave

Paid time off

Job summary

Legend Biotech USA Inc. in New Jersey seeks a Manufacturing Lead Operator, Aseptic Process to join the Manufacturing & Operations team in Raritan.

This role will oversee CAR-T cell therapy operations in ISO 5 and ISO 7 environments, applying aseptic processing and cGMP principles to produce personalized cell therapy for clinical and commercial use. The ideal candidate holds a bachelor’s degree in life science or engineering, at least 2 years of cGMP operations experience, and strong

Qualifications

• Bachelor’s degree in life science/engineering or related field.
• Minimum 2 years of operations experience in a cGMP biotech/biopharma environment.
• Ability to build partnerships and operate in a matrixed environment.
• Strong verbal and written communication with attention to detail.
• Knowledge of cGMP regulations and FDA guidance for cell-based products.
• Ability to lift 50 lbs and stand for long periods.
• Willingness to work shift including evenings and weekends.
• Experience in aseptic manufacturing preferred.

Responsibilities

• Establish time management and prioritization on production duties.
• Support CAR-T manufacturing process development and risk analyses.
• Collaborate with engineering and quality to drive improvements and CAPAs.
• Provide floor oversight of CAR-T operations in ISO 5 and ISO 7 environments.
• Utilize data analysis to assess impacts across process areas.
• Interact with multiple departments to ensure safe, high-quality production.

Skills

Team collaboration

Problem solving

Communication

Shift flexibility

Education

Bachelor’s degree in life science/engineering

Job description

Legend Biotech USA Inc. in New Jersey seeks a Manufacturing Lead Operator, Aseptic Process to join the Manufacturing & Operations team in Raritan.

This role will oversee CAR-T cell therapy operations in ISO 5 and ISO 7 environments, applying aseptic processing and cGMP principles to produce personalized cell therapy for clinical and commercial use. The ideal candidate holds a bachelor’s degree in life science or engineering, at least 2 years of cGMP operations experience, and strong